RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.
PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.
OUTLINE: This is a multicenter study. Patients are stratified according to institution, WHO performance status (0 vs > 0), age (≤ 50 vs > 50), presence of 1p LOH only (yes vs no), presence of oligodendroglial elements (yes vs no), and O6-methylguanine-DNA methyltransferase promoter methylation status (methylated vs unmethylated vs indeterminate). Patients are randomized to 1 of 4 treatment arms.
NOTE: *Patients must begin radiotherapy within 8 days after randomization and within 7 weeks after surgery.
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires, including QLQ-C30 version 3, BCM20, and the Mini Mental Status Exam at baseline, 4 weeks after the completion of radiotherapy, and then every 3 months for 5 years.
Tissue samples are collected at baseline for histology review, 1p/19q analysis, methylation status of the O6-methylguanine-DNA methyltransferase promoter, and isocitrate dehydrogenase mutation analysis.
After completion of study treatment, patients are followed every 3 months.
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| U.S.A. |
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| Arizona |
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Phoenix |
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| | Arizona Oncology Services Foundation |
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| | David G. Brachman |
Ph: 800-360-6371 |
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| California |
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Los Angeles |
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| | Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center |
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| | Jeremy D Rudnick |
Ph: 310-423-8965 |
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| Florida |
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Gainesville |
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| | University of Florida Shands Cancer Center |
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| | Robert J Amdur |
Ph: 352-273-8675 |
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Email:
trials@cancer.ufl.edu |
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Jacksonville |
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| | Mayo Clinic - Jacksonville |
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| | Kurt A. Jaeckle |
Ph: 507-538-7623 |
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Orlando |
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| | Florida Hospital Cancer Institute at Florida Hospital Orlando |
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| | Robert J Sollaccio |
Ph: 407-303-5623 |
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| Georgia |
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Atlanta |
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| | Winship Cancer Institute of Emory University |
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| | Hui-Kuo G Shu |
Ph: 404-778-1868 |
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Savannah |
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| | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center |
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| | John Raymond Duttenhaver |
Ph: 912-350-8568 |
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| Illinois |
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Chicago |
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| | Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
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| | Priya U Kumthekar |
Ph: 312-695-1301 |
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Email:
cancer@northwestern.edu |
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| | University of Chicago Cancer Research Center |
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| | Martin K Nicholas |
Ph: 773-834-7424 |
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La Grange |
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| | La Grange Memorial Hospital |
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| | Jeffrey M Feinstein |
Ph: 630-654-1790 |
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Email:
info@hhoaltd.com |
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Maywood |
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| | Cardinal Bernardin Cancer Center at Loyola University Medical Center |
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| | Edward Melian |
Ph: 708-226-4357 |
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Normal |
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| | Community Cancer Center |
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| | Nguyet A Le-Lindqwister |
Ph: 800-793-2262 |
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Peoria |
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| | Illinois CancerCare - Peoria |
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| | Nguyet A Le-Lindqwister |
Ph: 800-793-2262 |
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| | OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC |
|
| | Nguyet A Le-Lindqwister |
Ph: 800-793-2262 |
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| | OSF St. Francis Medical Center |
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| | Nguyet A Le-Lindqwister |
Ph: 800-793-2262 |
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| Indiana |
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Fort Wayne |
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| | Parkview Regional Cancer Center at Parkview Health |
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| | Brian K Chang |
Ph: 260-373-8888 |
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Email:
parkviewresearch@parkview.com |
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| | Radiation Oncology Associates Southwest |
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| | Brian K Chang |
Ph: 260-373-8888 |
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Email:
parkviewresearch@parkview.com |
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| Iowa |
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| |
Ames |
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| | McFarland Clinic, PC |
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| | Joseph James Merchant |
Ph: 515-239-2621 |
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Sioux City |
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| | Siouxland Hematology-Oncology Associates, LLP |
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| | Donald Bruce Wender |
Ph: 712-252-0088 |
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| Kansas |
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Wichita |
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| | Via Christi Cancer Center at Via Christi Regional Medical Center |
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| | Shaker R. Dakhil |
Ph: 316-262-4467 |
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| | Wesley Medical Center |
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| | Shaker R. Dakhil |
Ph: 316-262-4467 |
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| Kentucky |
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Lexington |
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| | University of Kentucky Chandler Medical Center |
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| | William H St. Clair |
Ph: 859-257-3379 |
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Louisville |
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| | Louisville Oncology at Norton Cancer Institute - Louisville |
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| | Aaron C Spalding |
Ph: 502-629-2500 |
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| | Norton Suburban Hospital |
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| | Aaron C Spalding |
Ph: 502-629-2500 |
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| Maine |
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Scarborough |
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| | Maine Medical Center- Scarborough Campus |
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| | Ian J Bristol |
Ph: 207-396-8090 |
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Email:
wrighd@mmc.org |
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| Massachusetts |
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Boston |
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| | Boston University Cancer Research Center |
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| | Minh T Truong |
Ph: 617-638-8265 |
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| Michigan |
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Ann Arbor |
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| | Saint Joseph Mercy Cancer Center |
|
| | Swati Dutta |
Ph: 734-712-3456 |
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Detroit |
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| | Josephine Ford Cancer Center at Henry Ford Hospital |
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| | Eleanor M. Walker |
Ph: 313-916-1784 |
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Kalamazoo |
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| | West Michigan Cancer Center |
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| | Raymond Sterling Lord |
Ph: 269-373-7458 |
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| Minnesota |
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| |
Rochester |
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| | Mayo Clinic Cancer Center |
|
| | Nadia N Laack |
Ph: 507-538-7623 |
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Email:
laack.nadia@mayo.edu |
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| Missouri |
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Saint Louis |
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| | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
|
| | Clifford G Robinson |
Ph: 800-600-3606 |
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Email:
info@siteman.wustl.edu |
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| Nebraska |
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Omaha |
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| | Methodist Estabrook Cancer Center |
|
| | Tien-Shew W Huang |
Ph: 402-354-5144 |
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| | UNMC Eppley Cancer Center at the University of Nebraska Medical Center |
|
| | Nicole A Shonka |
Ph: 800-999-5465 |
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| New Hampshire |
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| |
Lebanon |
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| | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center |
|
| | Alan C. Hartford |
Ph: 800-639-6918 |
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Email:
cancer.research.nurse@dartmouth.edu |
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| New York |
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| |
New York |
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|
| | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center |
|
| | Andrew B Lassman |
Ph: 212-305-8615 |
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Rochester |
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| | Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester |
|
| | Yuhchyau Chen |
Ph: 585-275-5830 |
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| | James P. Wilmot Cancer Center at University of Rochester Medical Center |
|
| | Yuhchyau Chen |
Ph: 585-275-5830 |
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Syracuse |
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| | SUNY Upstate Medical University Hospital |
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| | Anna Shapiro |
Ph: 315-464-5476 |
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| Ohio |
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Akron |
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| | Summa Center for Cancer Care at Akron City Hospital |
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| | Charles A Kunos |
Ph: 800-641-2422 |
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Barberton |
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| | Barberton Citizens Hospital |
|
| | Charles A Kunos |
Ph: 800-641-2422 |
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Cleveland |
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| | Case Comprehensive Cancer Center |
|
| | Mitchell Machtay |
Ph: 800-641-2422 |
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| | Cleveland Clinic Taussig Cancer Center |
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| | Samuel T Chao |
Ph: 866-223-8100 |
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| | MetroHealth Cancer Care Center at MetroHealth Medical Center |
|
| | Bruce J. Averbook |
Ph: 216-778-8526 |
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Email:
kbauchens@metrohealth.org |
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Columbus |
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| | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center |
|
| | Arnab Chakravarti |
Ph: 866-627-7616 |
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Email:
osu@emergingmed.com |
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Mentor |
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| | Lake/University Ireland Cancer Center |
|
| | Mitchell Machtay |
Ph: 800-641-2422 |
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Middleburg Heights |
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| | Southwest General Health Center |
|
| | Mitchell Machtay |
Ph: 800-641-2422 |
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Orange Village |
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| | UHHS Chagrin Highlands Medical Center |
|
| | Samuel T Chao |
Ph: 866-223-8100 |
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| |
Salem |
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| | Cancer Care Center, Incorporated |
|
| | William F. Demas |
Ph: 330-615-4132 |
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| |
Westlake |
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| | UHHS Westlake Medical Center |
|
| | Mitchell Machtay |
Ph: 800-641-2422 |
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Wooster |
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| | Cancer Treatment Center |
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| | William F. Demas |
Ph: 330-615-4132 |
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| Pennsylvania |
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Abington |
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| | Rosenfeld Cancer Center at Abington Memorial Hospital |
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| | Wayne H Pinover |
Ph: 215-481-2402 |
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Allentown |
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| | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest |
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| | Eliot Lawrence Friedman |
Ph: 610-402-2273 |
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| |
Bethlehem |
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| | St. Luke's Cancer Network at St. Luke's Hospital |
|
| | Nimisha Deb |
Ph: 610-954-3582 |
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Email:
infolink@slhn.org |
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| |
Hershey |
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| | Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center |
|
| | Henry Wagner |
Ph: 717-531-3779 |
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Email:
CTO@hmc.psu.edu |
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Philadelphia |
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| | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia |
|
| | Wenyin Shi |
Ph: 215-955-6084 |
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West Reading |
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| | McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center |
|
| | Albert Yuen |
Ph: 610-988-9323 |
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| South Carolina |
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| |
Charleston |
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| | Hollings Cancer Center at Medical University of South Carolina |
|
| | Pierre Giglio |
Ph: 843-792-9321 |
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Greenville |
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| | Cancer Centers of the Carolinas - Faris Road |
|
| | David L Grisell |
Ph: 864-241-6251 |
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| | CCOP - Greenville |
|
| | David L Grisell |
Ph: 864-241-6251 |
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| |
Greer |
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| | Cancer Centers of the Carolinas - Greer Radiation Oncology |
|
| | David L Grisell |
Ph: 864-241-6251 |
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| |
Seneca |
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| | Cancer Centers of the Carolinas - Seneca |
|
| | David L Grisell |
Ph: 864-241-6251 |
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Spartanburg |
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| | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center |
|
| | Patricia C Griffin |
Ph: 800-486-5941 |
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| South Dakota |
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| |
Rapid City |
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| | Rapid City Regional Hospital |
|
| | Michael J Swartz |
Ph: 605-716-3982 |
| |
Email:
research@rcrh.org |
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| Texas |
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| |
Austin |
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|
| | University Medical Center Brackenridge |
|
| | Brian D Vaillant |
Ph: 512-324-7991 |
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| |
Galveston |
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|
| | University of Texas Medical Branch |
|
| | Martin Colman |
Ph: 409-772-1950 |
| |
Email:
clinical.research@utmb.edu |
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| |
Houston |
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| | Methodist Hospital |
|
| | Pamela Z New |
Ph: 713-790-2700 |
|
| | Univeristy of Texas M.D. Anderson Cancer Center |
|
| | John F de Groot |
Ph: 713-792-3245 |
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| Utah |
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| |
Murray |
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|
|
| | Jon and Karen Huntsman Cancer Center at Intermountain Medical Center |
|
| | R. Jeffrey Lee |
Ph: 801-507-3950 |
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| |
Ogden |
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|
| | Val and Ann Browning Cancer Center at McKay-Dee Hospital Center |
|
| | R. Jeffrey Lee |
Ph: 801-507-3950 |
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| |
Provo |
|
|
| | Utah Valley Regional Medical Center - Provo |
|
| | R. Jeffrey Lee |
Ph: 801-507-3950 |
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| |
Saint George |
|
|
| | Dixie Regional Medical Center - East Campus |
|
| | R. Jeffrey Lee |
Ph: 801-507-3950 |
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| |
Salt Lake City |
|
|
| | Huntsman Cancer Institute at University of Utah |
|
| | Dennis C. Shrieve |
Ph: 801-581-4477 |
| |
Email:
clinical.trials@hci.utah.edu |
|
| | LDS Hospital |
|
| | R. Jeffrey Lee |
Ph: 801-507-3950 |
|
| Virginia |
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| |
Richmond |
|
|
|
| | Virginia Commonwealth University Massey Cancer Center |
|
| | Douglas W Arthur |
Ph: 804-628-1939 |
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| Washington |
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| |
Everett |
|
|
|
| | Providence Regional Cancer Partnership |
|
| | Yoshio Inoue |
Ph: 253-403-2394 |
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| |
Seattle |
|
|
| | CCOP - Virginia Mason Research Center |
|
| | Huong T. Pham |
Ph: 800-354-9527 |
|
| | University Cancer Center at University of Washington Medical Center |
|
| | George E. Laramore |
Ph: 206-616-8289 |
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| |
Tacoma |
|
|
| | CCOP - Northwest |
|
| | Yoshio Inoue |
Ph: 253-403-2394 |
|
| West Virginia |
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| |
Morgantown |
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|
|
| | Mary Babb Randolph Cancer Center at West Virginia University Hospitals |
|
| | Manish A Monga |
Ph: 304-293-2745 |
| |
Email:
sfilburn@hsc.wvu.edu |
|
| Wisconsin |
|
| |
Green Bay |
|
|
|
| | Green Bay Oncology, Limited at St. Mary's Hospital |
|
| | Gregory M. Cooley |
Ph: 920-433-8889 |
|
| | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center |
|
| | Gregory M. Cooley |
Ph: 920-433-8889 |
|
| | St. Mary's Hospital Medical Center - Green Bay |
|
| | Gregory M. Cooley |
Ph: 920-433-8889 |
|
| | St. Vincent Hospital Regional Cancer Center |
|
| | Gregory M. Cooley |
Ph: 920-433-8889 |
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| |
La Crosse |
|
|
| | Gundersen Lutheran Center for Cancer and Blood |
|
| | Collin D Driscoll |
Ph: 608-775-2385 |
| |
Email:
cancerctr@gundluth.org |
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| |
Madison |
|
|
| | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center |
|
| | Steven P Howard |
Ph: 877-405-6866 |
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| |
Milwaukee |
|
|
| | Froedtert Hospital and Medical College of Wisconsin |
|
| | Colleen A. Lawton |
Ph: 414-805-4380 |
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| |
Waukesha |
|
|
| | Waukesha Memorial Hospital Regional Cancer Center |
|
| | Wingate F. Clapper |
Ph: 262-928-7632 |
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| Canada |
|
| Alberta |
|
| |
Calgary |
|
|
|
|
| | Tom Baker Cancer Centre - Calgary |
|
| | Jacob C Easaw |
Ph: 403-521-3433 |
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| Manitoba |
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| |
Winnipeg |
|
|
|
| | CancerCare Manitoba |
|
| | Marshall W Pitz |
Ph: 866-561-1026 |
| |
Email:
CIO_Web@cancercare.mb.ca |
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| Ontario |
|
| |
Toronto |
|
|
|
| | Princess Margaret Hospital |
|
| | Warren P Mason |
Ph: 416-946-4501 |
| |
Email:
clinical.trials@uhn.on.ca |
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| Quebec |
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| |
Montreal |
|
|
|
| | Hopital Notre-Dame du CHUM |
|
| | Giuseppina L Masucci |
Ph: 514-890-8000ext23611 |
| |
Email:
sylvie.beaudoin.chum@ssss.gouv.qc.ca |
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| Saskatchewan |
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| |
Regina |
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|
|
| | Allan Blair Cancer Centre at Pasqua Hospital |
|
| | Muhammad Salim |
Ph: 306-766-2213 |
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